Rapid HPTLC Determination of Rosiglitazone in Pharmaceutical Formulations

Abstract

A new, simple, rapid, and stability‐indicating high‐performance thin layer chromatographic (HPTLC) method has been developed and validated for the determination of rosiglitazone in tablets. Analysis was performed on silica gel 60F₂₅₄ plates in horizontal chambers with chloroform–ethyl acetate–25% ammonium hydroxide (5:5:0.1, v/v) as mobile phase. Detection and quantification were performed by classical densitometry at 240 and 254 nm. The active substance was extracted from tablets with ethanol. Calibration plots were constructed in the range 0.2–1.0 µg/10 µL and were correlated with good correlation coefficients (r ₂₄₀ = 0.9993; r ₂₅₄ = 0.9994). Precision was validated by replicate analyses of standard solutions, and accuracy by analysis of fortified samples. The precision of the proposed chromatographic method, expressed as mean RSD was 3.58 and 2.76% for 240 nm, and 8.23 and 6.56% for 254 nm, for the lowest and the highest calibration levels, respectively. The mean recoveries from the fortified samples ranged from 89.48% to 99.38% for 240 nm, and from 89.05% to 100.89% for 254 nm. The mean recoveries from tablets were 101.95% and 103.2% for assays at 240 and 254 nm, respectively.

Keywords:

• Rosiglitazone
• HPTLC
• Densitometry
• Tablets